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A Drug Recall That Should Frighten Us All About The FDA

Pay attention, as I can’t say this seriously enough. Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax LaboratoriesImpax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t.

Background

In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA. The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose. The FDA approved generic versions of both dosage strengths from a few generic drug companies: Teva Pharmaceuticals (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals), Anchen, Actavis, Watson PharmaceuticalsWatson Pharmaceuticals and MylanMylan Pharmaceuticals. Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.

The People’s Pharmacy, a well-known syndicated radio and newspaper columnist husband and wife team, notified the FDA that hundreds of patients had logged their own complaints of side effects with the then-recently approved generic version of Wellbutrin XL. The FDA brushed off the People’s Pharmacy and others that raised the issue, stating that they had faith that the drugs were equivalent and that perhaps the patients, who had mental disease, were more prone to perceived problems with a change in the medication than others. This was seen by many as essentially telling patients “it’s all in their head.” After several more years and public outcry, the FDA was forced to take action.

What Action Did The FDA Take?

Instead of doing its own study on the drug, the FDA asked the drug maker to conduct a study to determine whether the generic drug was equivalent to the brand. The FDA, in their recent press release, claims that Teva started the trial but later abandoned it because of slow patient enrollment. It was already 2010, several years after knowing there was a problem, the FDA was forced to do its own study.

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Surprise – someone who works for pharma and generics finds my criticism alarmist. The seizure risk was not so high as to make the FDA not do a study – they did and it showed what people suspected.

I am glad you think the FDA does a good job – unfortunately, without public disclosure of complaints and correspondence, you say this with no basis other than you have not dropped dead from taking one. The article is about silent side effects of ineffective drugs. Please save your explanation to the parents of a patient who killed himself because they were put on an ineffective Wellbutrin XL and killed himself. The FDA cannot be perfect, but waiting two months to tell the public when it had the information in hand is criminal in my opinion.

This is ridiculous.. Hell I could go on anyone of the “junkie” sites and after 2 minutes of reading threads know that not all drugs are even created the same.. Different brands, different binders.. if the binders are wrong.. then the drug isn’t released correctly to the blood stream. Im not even a PHD.. hell Im not even a college grad an know this!

One must agree with every bit of alarum raised by this particular issue and its wider implications. I believe Commissioner Hamburg is doing everything humanly possible to help the FDA rise up and live out its creed–but like most government agencies, is hog-tied by the monied interests of corporations. (There’s not even a thin veil about it; note the Monsanto watchdog openly appointed to the FDA.) Do you suppose FDA procedures relying on testing by the company of origin are by choice? Ask if they have the funding to do otherwise. And whether this might have changed since the Reagan administration, when political efforts to “drown government in a bathtub” commenced. My only surprise is that Forbes would publish such a public-good oriented piece.

This makes complete and total sense to me now. I was never on the 150mg, but my doctor prescribed me the 300mg to help me stop smoking (wellbutrin has long been used as an anti-smoking medication, and doesn’t have the horrid side effects of the main one available on the market today). 3 weeks into taking them, I had quit smoking, but I also wrote a suicide text message and sent it to my best friend, who caught me parked on the end of a bridge near my home getting ready to walk to the middle and jump and stopped me. I have no idea where that even came from. All I know is that I told my doctor the next day and he said “My God stop taking it immediately, something is wrong” and I did. I felt great within a week. I have NEVER been suicidal in my life, but this medication, while it was helping me to quit smoking (I have since started back and have decided it’s better to live now and smoke than to take a medication and commit suicide as a non-smoker…priorities ya know), actually made me a depressed person. All my friends noticed, but I couldn’t. I wasn’t as “funny” as I normally was, was tired all day, it was like an induced depression. So yea, this makes complete and total sense to me that there was something wrong with the drug. I wonder which lawyer I need to contact to get a case started.

This is not the same problem. You never took the brand name drug or a different dose. You most likely also didn’t take the extended release version [XL]which is what this article references. What you experienced was a phenomenon associated with the antidepressants from this era. There are reports of people becoming suicidal, especially when first beginning a drug. There are now black box warnings about this. With some drugs this showed up even in trials. It’s driven by the biochemical differences between people.